Device for cardiac valve repair and method of implanting the same

ABSTRACT

The present invention relates to a device for cardiac valve repair, the device comprising: at least one upstream anchoring means adapted to anchor to at least one tissue site, the tissue site located upstream with respect to a heart valve of a patient; and a coaptation structure arranged to extend from the upstream anchoring means, the coaptation structure comprising a free end, wherein the coaptation structure is operable to extend across the heart valve and locate the free end downstream from the heart valve and the coaptation structure operable to coapt with at least one heart valve leaflet of the patient&#39;s heart to prevent and/or minimize a backflow of blood. The present invention is suitable for the treatment of heart valves using minimally invasive approaches. Additionally, the present invention is directed to a method of implanting a device for cardiac valve repair in a patient&#39;s heart.

FIELD OF INVENTION

The invention relates to the field of implantable medical devices, inparticular to cardiac valve repair devices and methods of implanting thesame. The invention is suitable for transcatheter and minimally invasiveheart valve treatment, in particular for repair of a non-functionaltricuspid or mitral heart valve.

BACKGROUND OF INVENTION

Rationale

Tricuspid regurgitation (TR) affects millions of people worldwide. It isdifficult to treat and even surgical repair can fail. Some studies haveshown long term moderate to severe recurrent TR of up to 30% in patientswho receive surgical repair¹. TR can result in significant complicationssuch as pulmonary hypertension, right heart failure, liver cirrhosis andthe complications associated with right heart failure (eg. venousulcers). Current treatment is largely medical with the use of diureticssuch as Lasix and spironolactone. There has been no randomized trialshowing the superiority of one treatment option over another.

The problem with TR is that it is seldom isolated. It often occurstogether with other valvular heart disease or in the presence of heartfailure or pulmonary hypertension. If surgery is performed for theprimary valve disease, the tricuspid valve may be repaired or replacedat the same time. However, for many patients, the development of severeTR is a late manifestation and even when the primary pathology istreated, the TR can remain a problem. This is because the rightventricle (RV) and the tricuspid annulus remodels and this seldomreverses. In other instances, the underlying pathology cannot bereversed, e.g. primary pulmonary hypertension or ischemiccardiomyopathy, but the secondary TR itself is a cause of significantmorbidity and frequent hospitalization.

Clinical Need and Current Treatment Limitations

The current treatment for TR is either medical therapy or surgery.However surgery is of limited efficacy and significant risk. Recurrenceafter concomitantly performed with Mitral Valve (MV) surgery: 15% at 1month, 31% at 8 years²; also dependent on repair technique e.g., ringannuloplasty 17%, Bicuspidization 14%^(2,3). There are current noworking percutaneous models of TR repair or Tricuspid Valve (TV)replacement although it is believed that a few companies andinvestigators have started work in the area. Clinical studies inpatients are still lacking. Current approaches aim to replace thefunction of the tricuspid valve by implanting a stented valve asreplacement of the native valve or by implanting stented valve in theinferior vena cava and the superior vena cava. By doing so, this lastmethod aims to obviate the problem of tricuspid regurgitation byremoving the function of the right atrium. The current approaches aredifficult in practice because of the large variation in tricuspid valveand vena cava anatomies. In addition, the vena cava approach is limitedby the non-physiologic re-arrangement of human anatomy and does not takeinto account effects of high right-sided cardiac pressures, which maycontinue its deleterious effects on the lungs.

The prevalence of isolated TR is poorly defined but approximates 0.8% to3.8%^(4,5). Its effects are more commonly seen in patients withunderlying left sided valvular heart disease such as in mitral stenosisor mitral regurgitation, ranging from 37 to 74%⁶⁻⁸. The clinical burdenof TR is clear with right-sided heart failure refractory to treatment.Patients are prone to recurrent admissions. Other than symptomaticrelief, there is no drug-therapy that has been shown in randomizedtrials to improve long-term prognosis.

It is one objective of the present invention to provide a minimallyinvasive and simple approach to treat valve regurgitation and avoidlimitations associated with predicate minimally invasive heart valvetreatment approaches. It is another objective of the proposed presentinvention to be implanted without general anaesthesia and/or open heartsurgery.

It is a further objective of the present invention to avoid thedisadvantages associated with complete heart valve replacement deviceswhich cannot accommodate suitably for different valve annulus sizes andmay require a complex delivery systems for implantation. The proposeddevice according to the present invention is designed with an objectiveof accommodating for various valvular anatomies and diseases.

SUMMARY OF THE INVENTION

The present invention seeks to address and/or ameliorate the problems inthe prior art by providing a device for cardiac valve repair that issimple, capable of accommodating different valvular anatomies anddiseases and is suitable for minimally invasive implantation approaches.

According to an aspect of the present invention, there is provided adevice for cardiac valve repair, the device comprising: at least oneupstream anchoring means adapted to anchor to at least one tissue site,the tissue site located upstream with respect to a heart valve of apatient; and a coaptation structure arranged to extend from the upstreamanchoring means, the coaptation structure comprising a free end, whereinthe coaptation structure is operable to extend across the heart valveand locate the free end downstream from the heart valve and thecoaptation structure operable to coapt with at least one heart valveleaflet of the patient's heart to prevent and/or minimize a backflow ofblood.

The fact that the coaptation structure that is operable to extend acrossa heart valve to locate the free end of the coaptation structuredownstream from the heart valve, allows the coaptation structure to,without hindrance and restriction (e.g. via a downstream anchor),effectively replace and/or support the coaptation function of a failingvalve leaflet, and/or to act as an additional support for coaptation ofthe valve leaflets which are spaced further apart due to for example,annular dilatation. Locating the free end of the coaptation structuredownstream from the heart valve allows for optimal efficiency in thecoaptation of the coaptation structure and the valve leaflets.

Preferably, the coaptation structure is flexible.

Preferably, the coaptation structure comprises a balloon having asurface for coaptation of at least one heart valve leaflet of thepatient's heart. More preferably, the balloon is expandable.

Preferably, the device further comprises a connecting means adapted toconnect the upstream anchoring means and the balloon, wherein theconnecting means is adapted to arrange the balloon at a first locationbetween two or more heart valve leaflets of the patient's heart.

Preferably, the coaptation structure comprises a neo-leaflet. Morepreferably, the neo-leaflet comprises a means for providing structure tothe neo-leaflet and wherein said means is flexible. Even morepreferably, the neo-leaflet comprises a polymer, fabric, tissue orcombination thereof. Preferably, the neo-leaflet is expandable.

Preferably, the device further comprises a connecting means adapted toconnect the upstream anchoring means and the neo-leaflet, wherein theconnecting means is adapted to arrange a portion of the neo-leaflet at afirst location between two or more heart valve leaflets of the patient'sheart.

Preferably, the neo-leaflet is extendable onto a surface of at least oneheart valve leaflet of the patient's heart.

Preferably, at least a portion of the neo-leaflet is extendable into acommissure between two adjacent heart valve leaflets of the patient'sheart.

Preferably, the device comprises a stabilizing structure adapted toextend across the heart valve of the patient, and wherein thestabilizing structure is configured to maintain the downstream locationof the free end of neo-leaflet. More preferably, the stabilizingstructure comprises a weighted free end.

Preferably, the stabilizing structure comprises one or more stabilizingtether adapted to connect the stabilizing structure to the neo-leaflet.More preferably, the stabilizing tether is adapted to connect to thefree end of the neo-leaflet.

Preferably, the coaptation structure comprises a membrane, wherein aportion of the membrane is extendable into a commissure between twoadjacent heart valve leaflets of the patient's heart.

Preferably, the upstream tissue site is a blood vessel and the upstreamanchoring means is a stent.

Preferably, the heart valve is a tricuspid valve. More preferably, thestent is adapted to anchor at the coronary sinus of the patient's heart,and/or the stent is adapted to anchor at the inferior vena cava of thepatient.

Preferably, the device comprises a second upstream anchoring means,wherein the second upstream anchoring means is a stent adapted to anchorat the superior vena cava of the patient.

Preferably, the heart valve is a mitral valve and the stent is adaptedto anchor at a pulmonary vein of the patient's heart.

Preferably, the upstream anchoring means and the coaptation structureare separate components of the cardiac valve repair device and whereinthe upstream anchoring means and the coaptation structure are configuredto connect with one another, or optionally, the upstream anchoring meansand the coaptation structure are a unitary structure.

Preferably, the device is crimpable or compressible for transcatheterdelivery.

According to another aspect of the present invention, there is provideda method of implanting a device for cardiac valve repair in a patient'sheart, the method comprising the steps of:

-   -   a) delivering a device for cardiac valve repair to the patient's        heart, the device comprising at least one upstream anchoring        means and a coaptation structure arranged to extend from the        upstream anchoring means;    -   b) anchoring the upstream anchoring means to at least one tissue        site in the patient's heart, the tissue site located upstream        with respect to a heart valve of the patient's heart;    -   c) deploying the coaptation structure to extend across the heart        valve to locate a free end of the coaptation structure        downstream from the heart valve, and for the coaptation        structure to coapt with at least one heart valve leaflet of the        patient's heart to prevent and/or minimize a backflow of blood.

Preferably, the upstream anchoring means and the coaptation structureare separate components and the method comprises delivering the upstreamanchoring means and the coaptation structure separately to the patient'sheart. More preferably, the method further comprises the step ofconnecting the upstream anchoring means with the coaptation structure.Even more preferably, the upstream anchoring means and the coaptationstructure are connected via a connecting means.

Preferably, the method further comprises the step of testing andverifying the stability of the upstream anchoring means.

Preferably, the method comprises deploying the coaptation structurebefore anchoring the upstream anchoring means.

Preferably, the coaptation structure is expandable and the methodfurther comprises the step of expanding the coaptation structure.

Preferably, the upstream anchoring means is a stent and the methodcomprises anchoring the stent at the coronary sinus of the right atriumof the patient's heart, and deploying the coaptation structure such thatthe free end of the coaptation structure extends into the right heartventricle of the patient and the coaptation structure coapts with atleast one tricuspid valve leaflet of the patient's heart.

Preferably, the upstream anchoring means is a stent and the methodcomprises anchoring the stent at the inferior vena cava of the patient,and deploying the coaptation structure such that the free end of thecoaptation structure extends into the right heart ventricle of thepatient and the coaptation structure coapts with at least one tricuspidvalve leaflet of the patient's heart.

Preferably, the cardiac valve repair device comprises a second upstreamanchoring means, wherein the second upstream anchoring means is a secondstent and the method comprises anchoring the second stent at thesuperior vena cava of the patient.

Preferably, the upstream anchoring means is a stent and the methodcomprises anchoring the stent at a pulmonary vein of the left atrium ofthe patient's heart, and deploying the coaptation structure such thatthe free end of the coaptation structure extends into the left heartventricle of the patient and the coaptation structure coapts with atleast one mitral valve leaflet of the patient's heart.

Preferably, the delivery of the cardiac valve repair device is viatranscatheter delivery. More preferably, the delivery of the cardiacvalve repair device is under fluoroscopic or ultrasound imagingguidance.

Preferably, the coaptation structure comprises a neo-leaflet.

According to another aspect of the present invention, there is a devicefor cardiac valve repair, the device comprising: a first upstreamanchoring means adapted to anchor to a first tissue site in a patient'sheart; a second upstream anchoring means adapted to engage a secondtissue site in the patient's heart; and a flexible backflow barrierarranged between, and extending from the first and second upstreamanchoring means, wherein the first and second tissues site are locatedupstream with respect to a heart valve of the patient and the backflowbarrier is arranged close to the heart valve of the patient to preventand/or minimize backflow of blood.

Preferably, the backflow barrier is substantially planar. Preferably,the backflow barrier comprises a neo-leaflet having a flexible frame.More preferably, the neo-leaflet comprises a polymer, fabric, tissue orcombination thereof.

Preferably, the first upstream anchoring means is adapted to anchor atthe coronary sinus of the patient's heart and the second upstreamanchoring means is adapted to abut against a portion of the rightarterial wall of the patient's heart.

Preferably, the first upstream anchoring means is adapted to anchor atthe pulmonary vein of the patient's heart and the second upstreamanchoring means is adapted to abut against a portion of the leftarterial wall of the patient's heart.

According to another aspect of the present invention, there is a devicefor cardiac valve repair, the device comprising: an upstream anchoringmeans adapted to anchor to an upstream tissue site, the upstream tissuesite located upstream with respect to a heart valve of a patient; and aneo-leaflet arranged to extend from the upstream anchoring means,wherein the neo-leaflet is operable to extend across the heart valve andthe coaptation structure is operable to coapt with at least one heartvalve leaflet of the patient's heart to prevent and/or minimize abackflow of blood.

Preferably, the device comprises a downstream anchoring means configuredto extend from an end of the neo-leaflet, and wherein the downstreamanchoring means is adapted to anchor at a downstream tissue site withrespect to the heart valve of the patient.

Preferably, the downstream tissue site is an endocardial or pericardialtissue site of a heart ventricle of the patient.

Preferably, the upstream anchoring means is adapted to anchor at thecoronary sinus of the patient's heart or optionally, the upstreamanchoring means is adapted to anchor to a pulmonary vein of thepatient's heart.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will now be described, by way of example only,with reference to the accompanying drawings, which are for illustrativepurposes only and are therefore not drawn to scale, in which:

FIG. 1A is a schematic axial sectional view of a heart showing theanatomical relationship between the coronary sinus and the tricuspidvalve.

FIG. 1B is a perspective view of a 3D reconstruction of the heartsection of FIG. 1A.

FIG. 2 is a schematic coronal view of the heart of FIG. 1 showing theanatomical relationship between the coronary sinus and the tricuspidvalve. The coronary sinus is medial and superior to the tricuspid valve,generally above the posterior-septal commissure, although somevariability in the position and height may exist.

FIG. 3 is a schematic coronal section of the right heart atrium RA andventricle RV with the cardiac valve repair device according to anembodiment of the present invention. The device 10 comprises a stent 11anchored in the coronary sinus 6 and a deployable coaptation structure12 extending into the right ventricle RV, functioning as a one-way valverepair.

FIG. 4 is a schematic axial sectional view of the cardiac valve repairdevice according to an embodiment of the present invention as shown inFIG. 3, with the deployable coaptation structure 12 shaped as aneo-leaflet extending into the right ventricle.

FIG. 5A is a schematic side profile drawing of a cardiac valve repairdevice according an embodiment of the present invention, with a stent 11and a deployable coaptation structure 12 extending from the inferiorborder 11 a of the stent 11.

FIG. 5B is a schematic top down view of the device of FIG. 5A with astent 11 and a deployable coaptation structure 12 extending from theinferior border 11 a of the stent 11.

FIG. 5C is a schematic en-face view of a device of FIGS. 5A and 5B witha stent 11 and a deployable coaptation structure 12 extending from theinferior border 11 a of the stent 11.

FIG. 6 is a schematic view of a cardiac valve repair device according toan embodiment of the present invention, with a deployable coaptationstructure 112 connected to the stent 111 by tethers 113.

FIG. 7 is a schematic view of a cardiac valve repair device according toan embodiment of the present invention, with a stent 211 implanted in acoronary sinus 6 above the valve 2 and a coaptation structure 212 withan expanded portion 214 located in the middle of the valve 2 providing asupport for the coaptation of a heart valve leaflet.

FIG. 8 is a schematic coronal view of a left side of the heart with animplanted device according to the embodiment as shown in FIGS. 5A to 5C.The device comprises an anchoring stent 11 implanted in a pulmonary vein7 above the mitral valve 3, with a coaptation structure 12 extending inbetween the mitral valve leaflets.

FIG. 9A is a schematic axial view of the heart with a differentembodiment of a device (1) with an anchoring stent (2) and with adeployable valve repair structure shaped as a membrane wall structureextending between the leaflets (31), here between the septal andposterior leaflets.

FIG. 9B is a schematic coronal section view of a left heart atrium andventricle with an implanted cardiac valve repair device as shown in FIG.9A. The device comprises a stent 311 deployed in the ostium 6 a of bloodvessel 6 (coronary sinus) located above the valve 2 and a deployablecoaptation structure 312 extending between at least two of the valveleaflets 2 b, 2 c and functioning as a septum enhancing coaptation ofthe valve leaflets.

FIG. 10A is a schematic axial sectional view of a heart with a cardiacvalve repair device according to an embodiment of the present invention,with a deployable backflow barrier 412 having two legs 415 extendingbetween and superior to the leaflets of the tricuspid valve 2.

FIG. 10B is a schematic coronal section view of a right heart ventriclewith the cardiac valve repair device as shown in FIG. 10A. The deviceincludes a stent 411 deployed in the coronary sinus 6 located above thevalve 2 and a backflow barrier 412 deployed in the right atrium abovethe valve leaflets and with legs 415 extending to the opposite side/wallof the right atrium.

FIG. 11 is a schematic coronal sectional view of a right heart ventriclewith a cardiac valve repair device according to an embodiment of thepresent invention. The device comprises a stent 511 deployed in a vessellocated above the valve 2, a deployable coaptation structure 512extending into the right ventricle RV and a downstream anchoring means516 at the end of the coaptation structure 512.

FIG. 12A is a schematic coronal view of a heart with an implantedcardiac valve repair device according to an embodiment of the presentinvention, where the device comprises a stent 611 anchored to theinferior vena cava 9 and a deployable coaptation structure 612 from thestent 611 into the right ventricle RV.

FIG. 12B is a schematic axial sectional view of the heart of FIG. 12Aalong axis A-A′.

FIG. 13 is a schematic coronal view of a heart with an implanted cardiacvalve repair device according to an embodiment of the present invention,where the device comprises a stent 711 anchored to the inferior venacava 9, a deployable coaptation structure 712 from the stent 711 intothe right ventricle RV and a downstream anchoring means 716 at the endof the coaptation structure 712.

FIG. 14 is a schematic perspective view of a cardiac valve repair deviceaccording to the embodiment of FIGS. 5A to 5C.

FIG. 15 is a perspective and enlarged view of a 3D reconstruction of acardiac valve repair device according the embodiment of FIGS. 5A to 5C,implanted in the right atrium of a heart, where the stent 11 is anchoredat the coronary sinus 6, and the coaptation structure 12 extends intothe right ventricle via the tricuspid valve.

FIG. 16A is a perspective view of a 3D reconstruction of an implantedcardiac valve repair device according to an embodiment of the presentinvention. The device comprises a stent 811 anchored at the coronarysinus 6 with a coaptation structure 812 extending into the rightventricle RV. The device also comprises a stabilizing structure 817connected to the coaptation structure 812 via stabilizing tethers 818.

FIG. 16B is a perspective view of the device of FIG. 16A, viewed fromthe right ventricle.

FIGS. 17A to 17F illustrate steps of a method for delivering, deployingand implanting a cardiac valve repair device according to an embodimentof the present invention, where a stent 11 is implanted in the coronarysinus of a right heart atrium and a coaptation structure 12 extendsacross a tricuspid valve, from the stent 11.

FIGS. 18A to 18D illustrate steps of a method for delivering, deployingand implanting a cardiac valve repair device according to anotherembodiment of the present invention, where a stent 611 is implanted inan inferior vena cava and a coaptation structure 612 extends across atricuspid valve, from the stent 611.

FIGS. 19A to 19D illustrate steps of another method for delivering,deploying and implanting a cardiac valve repair device according to theembodiment of the present invention according to FIGS. 18A to 18D, wherea stent 611 is implanted in an inferior vena cava and a coaptationstructure 612 extends across a tricuspid valve, from the stent 611.

DETAILED DESCRIPTION OF THE INVENTION

Particular embodiments of the present invention will now be describedwith reference to the accompanying drawings. The terminology used hereinis for the purpose of describing particular embodiments only and is notintended to limit the scope of the present invention. Other definitionsfor selected terms used herein may be found within the detaileddescription of the invention and apply throughout the description.Additionally, unless defined otherwise, all technical and scientificterms used herein have the same meanings as commonly understood by oneof ordinary skill in the art to which this invention belongs. Wherepossible, the same reference numerals are used throughout the figuresfor clarity and consistency.

Throughout the specification, unless the context requires otherwise, theword “comprise” or variations such as “comprises” or “comprising, willbe understood to imply the inclusion of a stated integer or group ofintegers but not the exclusion of any other integer or group ofintegers.

Furthermore, throughout the specification, unless the context requiresotherwise, the word “include” or variations such as “includes” or“including” will be understood to imply the inclusion of a statedinteger or group of integers but not the exclusion of any other integeror group of integers.

Throughout the specification, a “patient” includes human and animalpatients. Accordingly, the cardiac valve repair device of the presentinvention is suitable for use in human hearts and animal hearts.

Medical terms, terminology and references used throughout thespecification will have ordinary meaning in the medical field and willbe understood by a skilled person in said field. Such terms, terminologyand references include but are not limited to “coapt”, “superior”,“inferior”, “posterior”, “anterior”, “proximal”, “distal”, “septal”,“atrium”, “ventricle” and “vena cava”. Anatomical terms and referencesare based on the standard anatomical position of the patient, forexample for humans, the anatomical position is a human standing erect,with feet facing forward, the arms at the sides, palms of the handsfacing forward with thumbs pointing away from the body and fingerspointing straight down. Therefore throughout the specification and asdepicted in the figures, the atrial end of a heart is considered abovethe ventricular end of the heart when the patient is in an anatomicalposition. In particular, the atrium is considered upstream from theventricle of a heart, where blood normally flows from the atrium to theventricle.

Throughout the specification, the terms “upstream” and “downstream” aretaken with reference to a heart valve being treated/repair, and withrespect to the normal flow of blood. For example, the right atrium RA isconsidered upstream to the right ventricle RV, since the right atrium RAis before the tricuspid valve and since blood normally flows from theright atrium RA to the right ventricle RV. Further, the right ventricleRV is considered upstream to the pulmonary artery, since the rightventricle RV is before the pulmonary valve and since blood normallyflows from the right ventricle RV to the pulmonary artery. As anadditional example and with reference to FIGS. 16A and 16B, the stent811 is located at an upstream location with respect to the tricuspidvalve 2 and the weighted end 816 a is located at a downstream locationwith respect to the tricuspid valve 2.

FIGS. 1A, 1B and 2 provide different views of the heart and itschambers. In particular, FIG. 2 shows the anatomical relationshipbetween the coronary sinus 6 and the tricuspid valve 2. A heart 1comprises a right atrium RA, right ventricle RV, left atrium LA and leftventricle LV. The right atrium RA and left atrium LA are respectivelyseparated from the right ventricle RV and left ventricle LV by thetricuspid valve 2 and mitral valve 3 (collectively known as theatrioventricular valves). The mitral valve 3 is also known as a bicuspidvalve. Further, the pulmonary artery (not shown) is separated from theright ventricle LV by the pulmonary valve 5 while the aorta (not shown)is separated from the right ventricle RV by the aortic valve 4. Thecoronary sinus 6 is medial and superior to the tricuspid valve 2,generally above the posteroseptal commissure 2 d, although somevariability in the position and height may exist. The coronary sinus 6is a collection of veins joined together to form a large vessel thatcollects deoxygenated blood from the heart muscle (myocardium), anddelivers it to the right atrium RA.

The native atrioventricular valves comprise flexible leaflets thatextend from an annulus inward towards one another, across the respectiveorifices. The leaflets come together or “coapt” in the flowstream toform the one-way fluid occluding surfaces. The leaflets come together atcommissures, e.g. posteroseptal commissure 2 d. Tricuspid valve 2comprises anterior leaflet 2 a, posterior leaflet 2 b and septal leaflet2 c while mitral valve 3 comprises anterior leaflet 3 a and posteriorleaflet 3 b. The heart 1 also comprises chordae tendineae (not shown)which are cord-like tendons in the ventricles and which connect thepapillary muscles to the tricuspid and mitral valve leaflets. Thechordae tendineae prevent the eversion and prolapse of the leaflets,especially during systole, by becoming tense and pulling the leaflets,holding them in closed positions.

The right atrium RA receives deoxygenated blood from the venous systemthrough the superior vena cava 8 and the inferior vena cava 9, while theleft atrium LA receives oxygenated blood from the lungs through thepulmonary veins 7. During ventricular diastole, blood in the atria ispumped through the tricuspid valve 2 and mitral valve 3 into theventricles, by contraction of the atria muscles and expansion(relaxation) of the ventricular muscles. During ventricular systole, theright ventricle RV contracts and pumps blood to the lungs via thepulmonary artery while the left ventricle LV contracts and pumps bloodto the rest of the body via the aorta. During ventricular systole, theleaflets of the tricuspid valve 2 and mitral valve 3 close to preventthe blood from regurgitating back from the ventricles into the atria.

The present disclosure provides exemplary embodiments directed tocardiac valve repair devices and methods of implanting the same, forimproving the function of a heart valve. Throughout the specification, aheart valve includes native and prosthetic/artificial heart valves.Therefore the cardiac valve repair device of the present invention isadapted to treat and/or repair native and prosthetic/artificial heartvalves. Further, a heart valve includes the tricuspid valve, mitral(bicuspid) valve, pulmonary valve and the aortic valve.

Individual components of the disclosed devices may be combined unlessmutually exclusive or otherwise physically impossible. Variousembodiments of anchoring means, connecting means and coaptationstructures are disclosed herein, and any combination of such elementsmay be made unless specifically excluded. For example, any of thecoaptation structures may be combined with any anchoring means whichincludes but are not limited to stents and clamps, even if notexplicitly disclosed. Likewise, the different constructions ofcoaptation structures may be mixed, matched and/or combined, such ascombining any tissue cover with a flexible frame, even if not explicitlydisclosed.

The present invention relates to a cardiac valve repair device and amethod of treating heart valve regurgitation using minimally invasiveapproaches, where the cardiac valve repair device aims to prevent,reduce and/or minimize regurgitation of blood flow across a diseasedand/or failing heart valve, or a failing prosthetic valve. The presentinvention also relates to a method of implanting the cardiac valverepair device. Further, the present invention relates to a new method ofrepairing or replacing the tricuspid valve. Additionally, the presentinvention is also directed to a method of delivering and producing suchdevice.

The present invention relates to the repair or treatment of diseasedheart valves or failing prosthetic heart valves using a minimallyinvasive or transcatheter implantable cardiac valve repair device. Thepresent invention relates to a method of treating heart valveregurgitation using minimally invasive approaches and a device whichaims to prevent, reduce and/or minimize regurgitation of blood flowacross the diseased and/or failing valve or failing prosthetic valve.Native valves may lose their ability to close properly due to severalreasons which include but are not limited to dilation of an annulusaround the valve, ventricular dilation, or a valve leaflet being flaccidcausing a prolapsing leaflet. Disease (e.g. rheumatic disease) may causevalve leaflet shrinkage, thereby leaving a gap in the valve between thevalve leaflets. Prosthetic heart valves can fail from for example wearand tear, fatigue and cavitation. Regurgitation is therefore a leakbackwards (i.e., from the outflow to the inflow side, or from downstreamto upstream) of blood resulting from the inability of the heart valve toclose properly. Heart valve regurgitation may seriously impair thefunction of the heart since more blood will have to be pumped throughthe regurgitating valve to maintain adequate circulation.

The present invention is intended to treat and repair theatrioventricular and semilunar valves, and in particular the tricuspidvalve. Therefore, anatomical structures of the right atrium RA and rightventricle RV will be explained in greater detail in the specificationherein, although it should be understood that the present invention mayequally be used to treat or repair the mitral valve, the pulmonary valveand the aortic valve.

Cardiac Valve Repair Device

In various embodiments, the cardiac valve repair device of the presentinvention comprises at least one upstream anchoring means implantableabove a diseased/failing valve and a coaptation structure extending intothe disease valve annulus as a means to restore function of the saiddiseased valve. The upstream anchoring means is preferably anchored(i.e. implanted) at a tissue site located upstream with respect to thediseased/failing valve, for example in the atrial wall.

The cardiac valve repair device of the present invention is preferably acatheter-delivered device that can be percutaneously delivered forexample via the venous system to the right side of the heart, althoughimplantation of the device of the present invention may be done by forexample open heart surgery. Percutaneous delivery can also be conductedvia the intercostal or subxyphoid space, or an endoscopic catheter-basedantegrade, retrograde, or trans-septal deployment, such methods as knownin the art. The entire catheter-delivery device may then comprise of:

-   -   1. A delivery catheter;    -   2. An anchoring means (upstream anchoring means); and    -   3. A deployable valve repair (coaptation) structure which aims        to restore the diseased/failing valve function.

The upstream anchoring means and the deployable coaptation structure maybe implanted and deployed separately, as a single entity or somecombination thereof. The deployable coaptation structure may beattachable to the anchoring means via a connecting means, which includesbut is not limited to tethers. The deployable coaptation structure andthe upstream anchoring means can be crimped/compressed to fit within thedelivery catheter and ejected, e.g. by an obturator, from the deliverycatheter to the target location, for example the upstream anchoringmeans being anchored to the coronary sinus.

The upstream anchoring means includes but is not limited to stents,clamps, hooks, tines, barbs, screws, and bioadhesives. Where theupstream anchoring means is for example a clamp or hook, the upstreamanchoring means is capable of piercing the intended tissue site foranchorage. Such upstream anchoring means can comprise tissue (natural orartificial/engineered), metal, metal alloy, polymer or other man-madematerial, or a combination thereof. One or more upstream anchoring meansmay be used to anchor and secure the device of the present invention toone or more upstream tissue sites. Where more than one upstreamanchoring means is used, the type of upstream anchoring means may bedifferent from one another. Preferably, the upstream anchoring means isa stent. The upstream anchoring means is preferably bio-inert and/orbiocompatible.

Examples of bioadhesives referred in the specification herein, includebut are not limited to synthetic polymer glues such as epoxy resins,epoxy putty, ethylene-vinyl acetate, phenol formaldehyde resins,polyamides, polyester resins, polypropylene, polysulfides, polyurethane,polyvinyl acetate, polyvinyl alcohol, polyvinyl chloride,polyvinylpyrrolidone, silicones and styrene acrylic copolymer; syntheticmonomer glues such as acrylnitrile, cyanoacrylate, acrylic andresorcinol glue; and solvent-type glues such as polystyrenecement/butanone and dichloromethane.

The coaptation structure includes but is not limited to balloons, flaps,leaflets and membranes. Preferably, the coaptation structure isflexible. Preferably, the coaptation structure is a neo-leaflet. In use,the coaptation structure coapts with at least one heart valve leafletand/or provides a surface on which at least one heart valve leaflet cancoapt against.

In various embodiments, the cardiac valve repair device may comprise astabilizing means that maintains the location of an end of thecoaptation structure in the ventricle.

In various embodiments, the device comprises one or more downstreamanchoring means adapted to anchor the device to a tissue site, at adownstream location with respect to the heart valve. The downstreamanchoring means may be an extension of the coaptation structure or thestabilizing means. The downstream anchoring means includes but is notlimited to clamps, hooks, tines, barbs, screws and bio-adhesives. Wherethe downstream anchoring means is for example a clamp or hook, thedownstream anchoring means is capable of piercing the intended tissuesite for anchoring. Such downstream anchoring means can comprise tissue(natural or artificial/engineered), metal, metal alloy, polymer or otherman-made material, or a combination thereof. One or more downstreamanchoring means may be used to anchor and secure the device of thepresent invention to one or more downstream tissue sites. Where morethan one downstream anchoring means is used, the type of downstreamanchoring means may be different from one another. The downstreamanchoring means is preferably bio-inert and/or biocompatible.

The cardiac valve repair device may be manufactured out of anitinol-titanium tube and manufactured by processes such as lasercutting, polishing and thermal molding in order to achieve aself-expandable implantable device comprising both an expanding stentstructure and the frame of the coaptation structure. The device may alsobe manufactured wholly or partly from tissue (includes natural andartificial/engineered). Preferably, such tissue comprises or is capableof simulating one or more physiological functions.

Stents

Stents may be made of tissue, metal, metal alloy, polymer or otherman-made material, or a combination thereof. Preferably, the stents ofthe present invention comprise elastic metals and/or metal alloys havingshape memory, which includes but are not limited to nitinol-titanium(nitinol), Cu—Zn—Al—Ni alloys and Cu—Al—Ni alloys. Preferably the stentof the present invention comprises nitinol-titanium which allows thestent to be crimped/compressed and which allows the stent to return toits original, uncrimped/uncompressed shaped when released from forexample, the delivery catheter. Nitinol-titanium can be processed to beaustenitic, martensitic and/or super elastic. Martensitic and superelastic metals/metal alloys can be processed to demonstrate requiredcompression/crimpable features.

Stents include laser cut stents or braided stents. In the manufacture oflaser cut stents, a laser cuts regular cut-outs in a thin isodiametricmetal/metal alloy tube. The tube is thereafter placed on a mold of thedesired shape, heated to the Martensitic temperature and quenched. Thetreatment of the stent in this manner will form a stent that has shapememory properties and will readily revert to the memory shape at thecalibrated temperature. Laser cut stents are preferably made fromnitinol-titanium, but may also be made from for example stainless steel,cobalt chromium, titanium, and other functionally equivalent metals andalloys.

Braided stents are constructed using braiding techniques. A metal/metalalloy wire is wound on a braiding fixture/mandrel in an over and underbraiding pattern until an isodiametric tube is formed from the wire. Acoupling tube made of stainless steel or nitinol-titanium is then usedto couple the loose ends of the wire. The loose ends are placed in thecoupling tube and crimped. The braided stent is thereafter placed on ashaping fixture and heated to a specified temperature to set the stentto the desired shape and to develop the martensitic or super elasticproperties desired.

The stent of the present invention may be made available in differentsizes. Different diameter stent sizes may be provided in variousembodiments of the device as the blood vessels (e.g. coronary sinus) inwhich the stent is to be anchored can be highly variable in size.Multiple diameters and lengths can be made available. As the stent ispreferably compressible/crimpable and expandable, the diametric size ofthe stent can be customized and configured to the blood vessel in whichit anchors, for example a balloon catheter can be made to radiallyexpand the stent such that the stents abuts and lodges into the tissueof a blood vessel so as to improve the anchorage and stability of thestent at the tissue site/blood vessel.

The stent of the present invention may be an expandable stent, and theexpandable stent may be self-expanding or balloon expandable.Preferably, the stent is flexible.

The stent may comprise tines and barbs arranged along an outer surfacethat latch onto tissue, to improve anchorage and stability of the stent.

Coaptation Structure

Various coaptation structures may be used in the cardiac valve repairdevice of the present invention. The coaptation structure is shaped toextend across a patient's heart valve and position/locate one of itsends downstream with respect to the heart valve, for example, thecoaptation structure is arranged to extend into a right heart ventricleacross a tricuspid valve. The coaptation structure preferably extendsinto the heart ventricle substantially via the centre of the heart valveannulus. In various embodiments, the coaptation structure or partthereof extends into the heart ventricle via the valve commissures, i.e.between adjacent valve leaflets.

The coaptation structure is constructed so as to provide sufficientstructural integrity to withstand the intracardiac forces withoutcollapsing. Choice of, shape and size of the coaptation structuredepends on a physician's preference, which in turn depends on forexample the patient's heart anatomy and condition. Importantly, thecoaptation structure allows blood to flow from the atrium into theventricle, without or with minimal regurgitation of flow, therebyrestoring valve function.

The coaptation structure includes but is not limited to balloons, flaps,leaflets and membranes. Throughout the specification where thecoaptation structure is a flap or leaflet, the coaptation structure willbe referred to as a “neo-leaflet”, to differentiate the coaptationstructure of the present invention, from the native valve leafletsand/or prosthetic valve leaflets that the cardiac valve repair device isintended to treat, repair and/or replace.

Preferably, the coaptation structure is flexible.

The coaptation structure can be made from tissue, biocompatible and/orbio-inert materials or combinations thereof. Tissue includes but is notlimited to biological animal tissue which may be chemically stabilized,for example bovine (cow) pericardium, ovine (sheep) pericardium, porcine(pig) pericardium or equine (horse) pericardium, and engineered tissue.

Biocompatible and/or bio-inert materials include but are not limited tometals, fabrics and polymers. Biocompatible polymers include but are notlimited to polyurethane, polyethylene terephthalate (PET),polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK),polystyrene-b-polyisobutylene-b-polystyrene (SIBS), polyester,polycarbonate urethane, polycarbonate silicone, polyether urethane,segmented polyether urethane, silicone polyether urethane, silicone,polycarbonate urethane, ultrahigh molecular weight polyethylene,polyolefin, elastomers, nylon, polyethylene-glycols, polyethersulphones,polysulphones, polyvinylpyrrolidones, polyvinylchlorides, otherfluoropolymers, silicone polyesters, siloxane polymers and/or oligomers,polylactones and block co-polymers.

The coaptation structure or part thereof may be treated with additives,for example, immunosuppressants and anti-coagulants (such as heparin).

In various embodiments, the coaptation structure comprises a structuralsupport frame which maintains the shape, size and flexibility of thecoaptation structure. The structural support frame may be made fromtissue (natural or artificial/engineered) metals, metal alloys,polymers, or a combination thereof. Preferably the structural supportframe is made from elastic metals and/or metal alloys having shapememory, which includes but are not limited to nitinol titanium(nitinol), Cu—Zn—Al—Ni alloys and Cu—Al—Ni alloys. More preferably, thestructural support frame is made from nitinol-titanium.

In various embodiments, the coaptation structure is a balloon, where thestructural support frame (for example comprising structural ribs) whichprovides the shape of the balloon, can be covered by bioprosthetictissues and/or biocompatible synthetic materials. The balloon may be inthe form of a rounded structure, having a tubular, ovoid ornear-spherical shape that can act as a supporting occluding element,which can be centrally located within the heart valve being repaired, tofacilitate coaptation of the valve leaflets around the balloon toprevent flow regurgitation. In the particular cases of the mitral andtricuspid valves, the failing leaflets may not be coapting therebyleaving a gap in the valve that causes the regurgitation of flow fromthe ventricle into the atrium during the systolic phase. The balloon asan occluding coaptation structure, acts as a support that restores thecoaptation of the failing or prolapsing leaflet, thereby preventing flowfrom regurgitating from the ventricle back into the right atrium. Theballoon provides a surface for coaptation of at least one heart valveleaflet.

The balloon can have various radial shape profiles and such shapeprofiles may vary along the length of the balloon, for example one endportion of the balloon may be circular while the other end istriangular. The balloon can have various sizes (i.e. radial diameter)and lengths. The size and length of the balloon can depend on forexample, the size of the valve annulus and the length of the heart valveleaflets. The balloon is preferably shaped and sized to provide anexterior surface for the valve leaflets to coapt against. Preferably,the exterior surface of the balloon is continuous.

In various embodiments, the balloon is self-expandable upon delivery oris capable of being inflated in a similar fashion as a balloon catheter,e.g. via an external access port.

In various embodiments, the coaptation structure is a neo-leaflet, wherea wire (or a plurality of wires) is shaped to form the structuralsupport frame for the neo-leaflet, and the bioprosthetic and/orbiocompatible material covers the frame. The frame provides flexibilityto the neo-leaflet, such that the neo-leaflet is capable of functioningin a substantially similar manner as natural heart valve leaflets. Theneo-leaflet is capable of acting as an extension of a failing valveleaflet to restore valve coaptation and prevent leaflet prolapse. Invarious embodiments, the neo-leaflet may be formed from an animal tissuehaving an inherent structural frame such that the neo-leaflet does notrequire a separate structural support frame formed from a metal, metalalloy, polymer or a combination thereof.

The neo-leaflet can have various shapes and sizes, for example the shapeof a tricuspid valve leaflet or part thereof. The shape and size of theneo-leaflet depends on for example the length of the heart valveleaflets. Further, the neo-leaflet can have different thickness alongits length. In various embodiments, the neo-leaflet or part thereof isexpandable.

In various embodiments, the coaptation structure or part thereof may beinserted via a commissure in between two heart valve leaflets to theventricular side of the valve where once deployed, it prevents reflux offlow by acting as a one way valve together with the patient's heartvalve leaflets.

In various embodiments, the coaptation structure may be inserted in thecommissure in between two valve leaflets in order to act as a membranewall structure on which the leaflets can coapt, thereby preventing theirprolapse and flow regurgitation. In such embodiments, the coaptationstructure is a membrane.

Connecting Means

In various embodiments, the deployable coaptation structure and theupstream anchoring means are a single unitary structure. In othervarious embodiments, the deployable coaptation structure and upstreamanchoring means are separate structures, and the coaptation structure isattachable and securable to the upstream anchoring means by one or moreconnecting means. In various embodiments, the connecting means isadapted to arrange the coaptation structure at an intended location withrespect to the valve/valve leaflets, e.g. centre of a heart valve.

The connecting means may be integral with the coaptation structure orthe upstream anchoring means. The connecting means includes but is notlimited to tethers, screws, mechanical locks, hooks, magnets, sutures(regardless of calibre or material), fabric, plication, crimps, staples,rivets, adhesives and any other device, component or method typicallyused to assemble various elements in an implantable device. Theconnecting means is preferably biocompatible and/or bio-inert.

It should be conceivable that there may be different sizes and shapes ofthe components of the cardiac valve repair device of the presentinvention, available to account for the distance between the tissue siteat which the upstream anchoring means anchors and the heart valve beingtreated/repaired, and the size of the heart valve beingtreated/repaired. Therefore in various embodiments, the connecting meansis capable of varying the distance between the upstream anchoring meansand the coaptation structure, for example by varying its length.Therefore, the length of the connecting means will depend on theapplication of the present invention and requirements of the patientand/or the physician. Preferably, the connecting means is a tether(which includes rods and wires). A physician can measure the distancebetween the upstream anchoring means and the coaptation structure beforedetermining the optimal length of the connecting means.

Tethers may be made from biocompatible and/or bio-inert materials whichinclude but are not limited to polymers (such as PTFE andpolypropylene), metals, metal alloys (such as nitinol-titanium) andtissue (natural or artificial/engineered). Tethers may be formed from asingle wire or comprise more than one wire braided together. Tethers maybe inelastic or elastic. Tethers may be flexible, which can contributeto the flexibility of the coaptation structure of the present invention.

Stabilizing Means

In various embodiments, the cardiac valve repair device comprises astabilizing means that maintains an end of the coaptation structure at adownstream location with respect to a heart valve. The stabilizing meansmay be an extension of the coaptation structure, the upstream anchoringmeans or the connecting means. The stabilizing means extendssubstantially to a downstream location across the heart valve, e.g. intoa heart ventricle and is connected via for example tethers, to an end ofthe coaptation structure to maintain its downstream location. Suchtethers (stabilizing tethers) function in the similar manner likenatural chordae tendinae which prevent the prolapse retraction of thecoaptation structure, especially during systole, by becoming tense andpulling on the coaptation structure. In various embodiments where thecoaptation structure is a neo-leaflet, such tethers prevent the eversionand prolapse of the neo-leaflet, especially during systole, by becomingtense and pulling on the neo-leaflet.

The stabilizing means may be made from metals, metal alloys, polymers,tissue (natural or artificial/engineered) or a combination thereof. Thestabilizing means is preferably flexible and made from a shape memorymaterial. Preferably, the stabilizing means is made from a materialhaving a sufficiently high elasticity modulus that allows thestabilizing means to maintain its shape during operation. Thestabilizing means may be made from metal, metal alloy, polymer or otherman-made material, or a combination thereof. Preferably the stabilizingmeans comprises metals and/or metal alloys having shape memory, whichincludes but are not limited to nitinol titanium (nitinol), Cu—Zn—Al—Nialloys and Cu—Al—Ni alloys. Preferably the stabilizing means is madefrom nitinol-titanium.

In various embodiments, the stabilizing means comprises a weighted end.

In various embodiments, the stabilizing means comprises one or moredownstream anchoring means adapted to anchor the device to a tissuesite, at a downstream location with respect to the heart valve, e.g.ventricular side of the valve. The stabilizing means stabilize thecoaptation structure across the heart valve which may advantageouslyprevent the cardiac valve repair device from migrating over the cardiaccycle and over time.

The downstream anchoring means includes but is not limited to clamps,hooks, tines, barbs, screws and bio-adhesives. Where the downstreamanchoring means is for example a clamp or hook, the downstream anchoringmeans is capable of piercing the intended tissue site for anchoring.Such tissue sites include but are not limited to endocardial andpericardial tissue sites.

The downstream anchoring means may be integral with the stabilizingmeans and can comprise tissue (natural or artificial/engineered),metals, metal alloys, polymers or other man-made materials, or acombination thereof. One or more downstream anchoring means may be usedto anchor and secure the device of the present invention to one or moredownstream tissue sites. Where more than one downstream anchoring meansis used, the type of downstream anchoring means may be different fromone another. The downstream anchoring means is preferably bio-inertand/or biocompatible.

Method of Delivery, Deployment and Implantation of the Cardiac ValveRepair Device

The present invention includes methods of delivery, deployment andimplantation of the cardiac valve repair device of the presentinvention. The delivery of the cardiac valve repair device of thepresent invention may be a single or multi-step process. A method ofdelivering such device may comprise the use of a delivery catheterinserted through minimally invasive access and advanced by fluoroscopicand ultrasound (Echo) guidance. Echocardiographic and/or CT(computerized tomography) and/or MRI (magnetic resonance imaging)evaluation may be required pre-operatively to determine the3D-relationship between the tissue site (e.g. coronary sinus) and theheart valve (e.g. tricuspid valve). It is expected that patients with apacing lead in the coronary sinus or in the right ventricle may beunsuitable for this therapy. The methods of the present invention mayalso not be performed in patients with infective endocarditis.

In various particular embodiments, the method of delivery may includeusing access from the femoral vein, internal jugular or subclavian vein,to access the coronary sinus. A marker catheter may be used to size thecoronary sinus. This can be performed by an imaging modality such asultrasound echocardiography, Transesophageal echocardiography,intravascular ultrasound or by fluoroscopy with injection of contrast.The marker catheter is then exchanged for the delivery system, using aguidewire.

With the delivery system in place, the stent is deployed at the orificeof the coronary sinus and stability is verified. Stability testing mayinclude tug testing. The deployable coaptation structure is thendeployed, for example in the right atrium RA and guided into the rightventricle RV. This may be performed with a specialized catheter or partof the delivery catheter.

Alternatively, the coaptation structure is positioned directly in theright ventricle RV before full deployment, again by the deliverycatheter. Once the coaptation structure is deployed, echocardiographicand fluoroscopic assessment can be performed to confirm devicepositioning and adequate reduction of tricuspid regurgitation. Theupstream anchoring means (e.g. stent) of the device is then deployed tohold the coaptation structure in place as a secondary step.

Deployment of the coaptation structure may depend on its actual shapeand size. It may be unfurled, untwisted, unsheathed, or unrolled. It maybe deployed in a single or multi-step process.

In various embodiments, a delivery device, e.g. a delivery cathetercarries the cardiac valve repair device of the present invention, wherethe device comprises the upstream anchoring means (e.g. a stent) and thecoaptation structure (e.g. a neo-leaflet) as a single unitary structure.The coaptation structure may be deployed first followed by the upstreamanchoring means or vice versa. For example where the cardiac valverepair device is adapted to treat/repair a tricuspid valve, the upstreamanchoring means is a stent operable to anchor at the inferior vena cavaand the coaptation structure comprises a neo-leaflet, the neo-leafletcan be deployed in the right ventricle and then withdrawn partially intothe right atrium, and thereafter, the rest of the cardiac valve repairdevice is pulled back into the inferior vena cava where the stent isanchored to the inferior vena cava. Hence, the sequence of delivery ofthe cardiac valve repair device may be as follows:

-   -   delivery system (delivery catheter comprising the cardiac valve        repair device) is navigated from inferior vena cava to right        atrium into right ventricle across tricuspid valve;    -   the distal end of the neo-leaflet as the coaptation structure is        released into the right ventricle and unfurled as the delivery        catheter is pulled back into the right atrium where the proximal        part of the neo-leaflet will sit/locate; and    -   the catheter is pulled back further into the inferior vena cava        where the stent as the upstream anchoring means is deployed with        the neo-leaflet attached to the stent—the neo-leaflet may be        integral with the stent, or be attached to the stent via a        connecting means (e.g. bioadhesives, stitches, hooks and        tethers).

In various embodiments, the delivery, deployment and implantation of thecardiac valve repair device comprises a multi-step process where forexample, the upstream anchoring means, e.g. the stent is first deliveredand anchored to the coronary sinus or inferior vena cava before thecoaptation structure, e.g. neo-leaflet is delivered and secured to theupstream anchoring means, and deployed across the tricuspid valve.

In one aspect, the present invention relates to a method of treating orrepairing a heart valve by a minimally invasive approach, comprising thesteps of advancing an upstream anchoring means to an anchoring location(preferably a vessel ostium) of a heart chamber, in the vicinity of theheart valve and deploying the upstream anchoring means at the location,and deploying the deployable coaptation structure (e.g. a neo-leaflet)and ensuring the function of the coaptation structure to restore valvefunction. The procedure may include advancing an additional catheter topass the distal part of the coaptation structure across the valve. It isunderstood that these steps may be performed in a different reverseorder.

In a particular embodiment of a triscuspid valve repair, the inventionrelates to a method of delivering and implanting a cardiac valve repairdevice of the present invention, the method comprising the steps ofcatheterizing the coronary sinus and delivering the upstream anchoringmeans, and deploying a coaptation structure (e.g. neo-leaflet) acrossthe tricuspid valve to restore valve function. It is understood thateach of the steps described above may occur in a different order.

In a particular embodiment of a mitral valve repair, the inventionrelates to a method of delivering and implanting a cardiac valve repairdevice of the present invention, the method comprising the steps ofcatheterizing one of the pulmonary veins and delivering the upstreamanchoring means, and deploying a coaptation structure (e.g. aneo-leaflet) across the mitral valve to restore valve function. It isunderstood that each of the steps described above may occur in adifferent order.

In both tricuspid and mitral valve repairs, the delivery of the cardiacvalve repair device can be advanced in the right or left atrium, via thefemoral vein, internal jugular or subclavian vein and a transeptalpuncture.

It is understood that while particular cases of tricuspid and mitralvalve repair are described, a device according to the principles of thepresent invention may be used to correct valve regurgitation in theaortic valve or in the pulmonary valve as well.

In various embodiments, each component of the cardiac repair areretrievable and removable from a patient via the delivery cathetersystem.

Exemplary Embodiments of the Present Invention

Cardiac Valve Repair Device

FIGS. 1 and 2 are schematic views of the heart 1 showing the anatomicalrelationship between the different valve positions in an axial view(FIGS. 1A and 1B) and a coronal view (FIG. 2). The position of the ostiaof coronary sinus 6 and pulmonary veins 7 can be observed above thetricuspid valve 2 and the mitral valve 3 respectively. In FIG. 2, aguidewire 50 is shown advanced into the coronary sinus 6 from thesuperior vena cava 8. During heart minimally invasive procedures, aguidewire 50 is often used during the heart catheterization to obtain aguide path from the access point to a desired location and to advance aguiding catheter sheath and other catheters to that particular desiredlocation. Such a wire or guide catheter may be used here for advancingand delivering the cardiac valve repair device of the present inventioninto the coronary sinus 6.

FIGS. 3 to 5, 14 and 15 provide an embodiment of a cardiac valve repairdevice 10 of the present invention. FIG. 3 shows a schematic magnifiedview of the anatomy shown in FIG. 2, showing the right heart ventricleRV and tricuspid valve 2 with a cardiac valve repair device 10 accordingto an embodiment of the present invention. The cardiac valve repairdevice 10 comprises a stent 11 as an upstream anchoring means and aneo-leaflet 12 as a deployable coaptation structure. The neo-leaflet 12extends from the stent 11 at a border 11 a located at one end of thestent 11. Preferably, the neo-leaflet 12 extends from an inferior border11 a of the stent 11 such that when the device 10 is implanted in thecorrect orientation in the patient's heart, the neo-leaflet 12 ispositioned close to the heart valve for said neo-leaflet 12 to functionas described herein. The inferior border 11 a will be understood to be alower portion of an end of the stent 11 when the stent 11 is implantedin a correct orientation in for example the coronary sinus 6 (FIG. 5C).In various embodiments, the inferior border 11 a is the lowest tip of anend of the stent 11 when the stent 11 is implanted in a correctorientation. It will be appreciated that depending on the applicationand requirements, the neo-leaflet 12 (as the coaptation structure) isattachable to one or more portions of the stent 11 (as the upstreamanchoring means) which includes but is not limited to an inner luminalsurface, an outer luminal surface, and anywhere along the length of thestent 11, for example the end and medial portions of the stent 11.Preferably, the neo-leaflet 12 is attachable (e.g. via stitching, hooksand/or screws) to an inner border, surface, lumen and/or portion of thestent 11.

The stent 11 and neo-leaflet 12 form a unitary structure, where thematerial of the stent 11 is used to form a part of the neo-leaflet 12.With reference to FIG. 14, the stent 11 is made from a metal alloy,preferably nitinol-titanium, comprising a portion which extends to forma structural support frame 12 a that forms the leaflet/flap shape of theneo-leaflet 12. The structural support frame provides the neo-leaflet 12with a curved side profile as shown in FIG. 5A. Bioprosthetic material12 b is attached, e.g. via stitching, hooks and/or screws to thestructural support frame 12 a to complete the neo-leaflet 12. Thestructural support frame 12 a holds the neo-leaflet 12 in positionduring operation of the device 10 and provides the required rigidity tothe neo-leaflet 12 to prevent prolapse of the distal section of theneo-leaflet 12. The structural support frame 12 a also provides therequired flexibility for the neo-leaflet 12 to function in asubstantially similar manner as a normal native valve leaflet forcoaptation with the heart valve leaflets during operation. In variousembodiments, the neo-leaflet 12 comprises a shape that substantiallycorresponds to the medial portion of the septal leaflet 2 c.

In various embodiments, the stent 11 and neo-leaflet 12 are separatecomponents, and the neo-leaflet 12 is attachable to the stent 11 at theborder 11 a via means and methods disclosed herein, for example viastitching, bioadhesives, hooks and/or screws.

The stent 11 is implantable in a coronary sinus 6, with the border 11 apreferably located substantially at the ostium 6 a of the coronary sinus6. The stent 11 can be crimped/compressed and catheter delivered to thecoronary sinus 6 before being expanded and implanted in the coronarysinus 6. The stability of the stent 11 in the coronary sinus 6 can betested via tug testing. The neo-leaflet 12 is deployed and extendsacross the tricuspid valve 2 and into the right ventricle RV, preferablyvia a location (first location) substantially at the centre of thetricuspid valve 2. In particular, the neo-leaflet 12 extends across thetricuspid valve 2 to locate a free end 12′ of the neo-leaflet 12downstream from the tricuspid valve 2, in the right ventricle RV. Thefree end 12′ is preferably located downstream from the tricuspid valve 2at all times when in operation, i.e. during both systolic and diastolicphases. The free end 12′ is distal from the stent 11. The free end 12′is allowed to move substantially unrestricted during the cardiac cycle,but remains downstream from the heart valve. In various embodiments, thefree end 12′ is not anchored to a tissue site. When a heart valve isnon-functional and regurgitation is present, the leaflets of the valvetypically do not coapt together completely and instead of the valveclosing, flow is regurgitating through an area of the valve into theatrium, affecting the heart pumping mechanism. The neo-leaflet 12 actsas a mechanism to restore the tricuspid valve 2 function, which is toclose during the ventricular systolic phase in order for the blood inthe right ventricle RV to be ejected through the pulmonary valve 5. Asshown in FIGS. 3, 4 and 15, the neo-leaflet 12 extends onto at least oneof the native valve leaflets, extending beyond it to increase the lengthavailable for coaptation. Therefore in operation, the neo-leaflet 12 isan extension of and functions like the septal leaflet 2 c, which coaptsagainst the anterior leaflet 2 a and posterior leaflet 2 b duringventricular systole, thereby preventing, reducing and/or minimizingbackflow of blood (i.e. regurgitation). Preferably, the neo-leaflet 12extends substantially onto the septal leaflet 2 c. In variousembodiments, portions of the neo-leaflet 12 extend into the rightventricle RV at other locations, for example via a commissure in betweenvalve leaflets, for example commissure 2 d, between posterior leaflet 2b and septal leaflet 2 c.

The cardiac valve repair device 10 is advantageous because it can beimplanted efficiently via minimally invasive means known in the art. Thestent 11 can be easily anchored to the upstream tissue site which is ablood vessel, and the neo-leaflet 12 can be easily deployed to extendacross the failing valve to expeditiously restore valve functions bycoapting with the other valve leaflets.

FIG. 6 provides another embodiment of a cardiac valve repair device 110comprising a stent 111 and a neo-leaflet 112 which is attached to thestent 111 via connecting tethers (connecting wires) 113. The neo-leaflet112 is a petal/paddle-shaped flap. During operation of the device 110,the tethers 113 extend the deployed neo-leaflet 112 towards an intendedlocation (e.g. the centre between valve leaflets) in the heart valve,arrange and substantially maintain the orientation and position of theneo-leaflet 112 at the intended location(s). The positioning of theneo-leaflet 112 at the intended location(s) optimizes the efficiency ofthe device 110 in the repair/treatment of the heart valve by ensuringmaximal coaptation between the valve leaflets and the neo-leaflet 112.The tethers 113 are therefore preferably made from a shape memory metalalloy, e.g. nitinol-titanium, such that they can effectively maintainthe position of the neo-leaflet 112 at the intended location(s).

In FIG. 6, the stent 111, neo-leaflet 112 and tethers 113 are a singleunitary structure, where the tethers 113 extend from the stent 111 tothe neo-leaflet 112 and forms the shape and structure of the neo-leaflet112. It will however be appreciated that in other embodiments, the stent111 and the neo-leaflet 112 are separate components, which areattachable to one another via the tethers 113. The attachment point maybe at either or both ends of the tethers 113 (i.e. at the border 111 aand/or the neo-leaflet 112), or at a medial portion of the tethers 113.

The tethers 113 are preferably flexible, thereby providing additionalflexibility to the cardiac valve repair device 110 during operation. Thelength of the tethers 113 depends on the application of the presentinvention and the requirements of the patient and/or physician. Forexample, the tethers 113 can comprise a length that substantiallycorresponds to the distance of ostium 6 a of the coronary sinus 6 to thetricuspid valve 2, of a patient. To avoid substantial variations in thelength of the tethers 113 during operation, the tethers 113 arepreferably non-elastic.

FIG. 7 provides another embodiment of a cardiac valve repair device 210comprising a stent 211 implanted into the coronary sinus 6, tether 213and a coaptation structure 212 extending across the tricuspid valve 2and into the right ventricle RV via a central location between tricuspidvalve leaflets. During operation (i.e. during systolic and diastolicphase), the coaptation structure 212 extends across the tricuspid valve2 to locate a free end 212′ of the coaptation structure 212 downstreamfrom the tricuspid valve 2, in the right ventricle RV. The coaptationstructure 212 is a balloon 212 comprising a structure support frame 212a and an expandable portion 214 having a surface for coaptation with atleast one valve leaflet so as to prevent, reduce and/or minimize abackflow of blood, when in operation.

The expandable portion 214 can be self-expandable or can be expanded viaa balloon catheter. When in operation, the expandable portion 214 ispositioned within the valve 2 via tethers 213 such that the expandableportion 214 or a portion thereof, provides a support for coaptation ofvalve leaflets. Therefore the expandable portion 214 comprises a lengththat sufficiently extends into the ventricle between valve leaflets,thereby providing a support for coaptation of the valve leaflets. Suchlength can depend on for example, the distance between the upstreamtissue anchorage site and the valve, and/or the length of the heartvalve leaflet. It will be appreciated that the length of heart valveleaflets are often mismatched, and therefore the different lengths ofthe heart valve leaflets have to be taken into consideration whendetermining the length of the expandable portion 214 (or a neo-leaflet).Accordingly, the expandable portion 214 can extend the entire length(i.e. to the end) of the structural support frame 212 a or a partthereof.

In other embodiments, the coaptation structure 212 is an expandableneo-leaflet 212, where a portion of the neo-leaflet 212, e.g. theportion comprising the bioprosthetic tissue, is expandable.

FIG. 8 shows the cardiac valve repair device 10 of FIG. 5 implantedabove a mitral valve 3 in the left atrium LA of a heart. The stent 11 ofthe device 10 is implanted into a pulmonary vein 7 and a neo-leaflet 12extends from the stent 11 across the mitral valve and into the leftventricle LV. The neo-leaflet 12 preferably extends onto at least onemitral valve leaflet, and in between the mitral valve leaflets. Invarious embodiments, the device 10 comprises more than one upstreamanchoring means, i.e. more than one stent 11, that may be implanted inmore than one pulmonary vein 7 in the left atrium LA. The device 10functions in the same manner as described above in relation to FIGS. 3to 5, 14 and 15, for the tricuspid valve.

FIGS. 9A and 9B provides another embodiment of a cardiac valve repairdevice 310 comprises a stent 311 implanted in a coronary sinus 6, and acoaptation structure 312. The coaptation structure 312 is a membrane 312that is capable of extending between adjacent valve leaflets, e.g.posterior leaflet 2 b and septal leaflet 2 c, at the posteroseptalcommissure 2 d, into the right ventricle RV, where a free end 312′ ofthe membrane 312 is positioned downstream from the tricuspid valve 2, inthe right ventricle RV. The membrane 312 functions as a septum whichenhances coaptation of the valve leaflets 2 b, 2 c. The membrane 312preferably extends across the tricuspid valve 2 via commissure 2 d toact as a membrane wall structure on which the leaflets can coapt,thereby preventing their prolapse and flow regurgitation.

FIGS. 10A and 10B provides another embodiment of a cardiac valve repairdevice 410 comprising a stent 411 implanted into a coronary sinus 6,tethers 413, a backflow barrier 412, and legs 415 (second upstreamanchoring means). The legs 415 extend to the opposite side of the rightatrium RA, i.e. opposite from the coronary sinus 6. The backflow barrier412 is positioned by the tethers 413 and the legs 415 centrally aboveand close to the area of regurgitation (e.g. in between and superior tothe valve leaflets) to prevent regurgitation of the blood flow in thedefective valve during the cardiac cycle. The legs 415 maintainstability of the backflow barrier 412, which acts as a repair structureby preventing prolapse of defective valve leaflets.

In various embodiments, the backflow barrier 412 has substantially thesame structure as a neo-leaflet (e.g. neo-leaflet 12) of the presentinvention, although the backflow barrier 412 does not coapt with thevalve leaflets when in operation. In such embodiments, the backflowbarrier 412 comprises a flexible structural support frame that is shapedlike a leaflet or a flap, and a bioprosthetic tissue that is attached tothe frame. The backflow barrier 412 is preferably flexible. Preferably,the backflow barrier 412 is substantially planar.

The legs 415 can extend from the tethers 413 or from the end (distalfrom the stent 411) of the backflow barrier 412 depending on theapplication and requirements. The legs 415 may be part of a unitarystructure of the device 410 or a separate component attachable to thedevice 410. The ends of the legs 415 are shaped to engage/abut a wall ofthe atrium, which provides a resistive force to maintain the position ofthe device 410 and the backflow barrier 412 with respect to thetricuspid valve 2. In various embodiments, the ends of the legs 415 areconfigured to anchor to the wall of the atrium, for example the ends ofthe legs 415 comprise clamps that are adapted to pierce the atrial wallto anchor the device 410 in the atrium. The legs 415 may be made of thesame material as the stent 411, tether 413 and/or the structural supportframe of the backflow barrier 412. In various embodiments, the device410 may comprise a single leg 415 or more than two legs 415. Preferably,the device 410 comprises at least one leg 415 as a second upstreamanchoring means.

FIG. 11 provides another embodiment of a cardiac valve repair device 510comprising a stent 511 implanted into a coronary sinus, tethers 513, aneo-leaflet 512 that extends from the stent 511 via tethers 513 and adownstream anchoring means 516 distal from the stent 511. The downstreamanchoring means 516 is connected to an end of the neo-leaflet 512 distalfrom the stent 511, and may be unitary with the neo-leaflet 512. Inother embodiments where the downstream anchoring means 516 is a separatecomponent from the neo-leaflet 512, the downstream anchoring means 516is attachable to an end of the neo-leaflet 512 via means as described inthe specification herein. A downstream connecting means may be used toconnect the end of the neo-leaflet 512 and the downstream anchoringmeans 516.

The neo-leaflet 512 extends across the tricuspid valve 2 into the rightventricle RV, in between the tricuspid valve leaflets, where thedownstream anchoring means 516 is configured to anchor to a tissue sitein the right ventricle RV, downstream from the tricuspid valve 2. Thedownstream anchoring means 516 cooperates with the stent 511 and tethers513 to maintain the neo-leaflet 512 at the intended location between thevalve leaflets. Maintenance of the coaptation structure at the intendedlocation between the valve leaflets preferably avoids the coaptationstructure (for example where the coaptation structure is a balloon) fromgetting struck in an offset position in the commissures between thevalve leaflets, which can result in leakage of the valve.

Additionally, the downstream anchoring means 516 functions as arestraint in the prevention of prolapse of the neo-leaflet 512 into theright atrium RA, during right ventricular systole. The downstreamanchoring means 516 may be anchored at an endocardial or pericardialtissue site. The downstream anchoring means 516 can comprise tines,barbs, screws and/or clamps that are capable of piercing the cardiacwall for anchorage.

FIGS. 12A and 12B provides another embodiment of a cardiac valve repairdevice 610 comprising a stent 611 implanted in the inferior vena cava 9,and a neo-leaflet 612 that extends from the stent 611 into the rightventricle RV across the tricuspid valve 2, such that a free end 612′ ofthe neo-leaflet 612 locates in the right ventricle RV, downstream of thetricuspid valve 2. The device 610 can comprise tethers that lengthensthe device 610 to extend the neo-leaflet 612 into the right ventricleRV. In the present embodiment, the neo-leaflet 612 extends onto theanterior leaflet 2 a of the tricuspid valve 2.

In various embodiments, the device can comprise an additional upstreamanchoring means that anchors to a tissue site upstream from the heartvalve, for example, the device 610 can comprise a second stent that isimplantable into the superior vena cave, and cooperates with the stent611 in the inferior vena cava to secure and position the neo-leaflet 612at an intended location with respect to the tricuspid valve. In othervarious embodiments, the stent 611 may be implanted in the superior venacave instead of the inferior vena cava.

FIG. 13 provides another embodiment of a cardiac valve repair device 710comprising a stent 711 implanted in the inferior vena cava 9, aneo-leaflet 712 that extends from the stent 711 into the right ventricleRV across the tricuspid valve 2, and a downstream anchoring means 716distal from the stent 711 and extending from an end of the neo-leaflet712.

The neo-leaflet 712 extends into the right ventricle RV in between thetricuspid valve leaflets, where the downstream anchoring means 716 isconfigured to anchor to a tissue site in the right ventricle RV,downstream from the tricuspid valve 2. The downstream anchoring means716 cooperates with the stent 711 to maintain the neo-leaflet 712 at theintended location between the valve leaflets. Maintenance of thecoaptation structure at the intended location between the valve leafletspreferably avoids the coaptation structure (for example where thecoaptation structure is a balloon) from getting struck in an offsetposition in the commissures between the valve leaflets, which can resultin leakage of the valve.

Additionally, the downstream anchoring means 716 functions as arestraining means in the prevention of prolapse of the neo-leaflet 712into the right atrium RA, during right ventricular systole. Thedownstream anchoring means 716 may be anchored at an endocardial orpericardial tissue site. The downstream anchoring means 716 can comprisetines, barbs and/or clamps that are capable of piercing the cardiac wallfor anchorage.

FIGS. 16A and 16B provide another embodiment of a cardiac valve repairdevice 810 comprising a stent 811 implanted into a coronary sinus 6, aneo-leaflet 812 having a distal free end 812′ extending into the rightventricle across the tricuspid valve 2, a tether 813 connecting an endborder of the stent 811 to a proximal end of the neo-leaflet 812, and astabilizing means 817 that extends further into the right ventricle withrespect to the free end 812′. The neo-leaflet 812 preferably extendsonto at least one tricuspid valve leaflet. The stabilizing means 817extends from the tether 813 and/or the stent 811, below an inferiorsurface of the neo-leaflet 812 and into the right ventricle, across thetricuspid valve 2. In various embodiments, the inferior surface of theneo-leaflet 812 or a part thereof is connected to the stabilizing means817.

The stabilizing means 817 comprises a wire or a plurality of wiresformed from a shape memory metal alloy that is flexible, e.g.nitinol-titanium. The stabilizing means 817 is attached via one or morestabilizing tethers 818 to the neo-leaflet 812 at a portionsubstantially close to or at the free end 812′, such that thestabilizing means 817 forms an extension of the free end 812′. Thestabilizing means 817 is shaped (e.g. curved downwards towards aventricular apex) to maintain the free end 812′ of the neo-leaflet 812in the right ventricle during the cardiac cycle, by maintaining arestraining force in the direction downstream from the valve. Therefore,during a ventricular systole, the stabilizing means 817 exerts a counterforce in an opposite direction of the blood flow against the valve so asto prevent prolapse of the neo-leaflet 812. The stabilizing means 817exerts this tensional/restraining force via stabilizing tethers 818. Thestabilizing tethers 818 function like chordae tendineae which preventthe eversion and prolapse of the neo-leaflet 812, especially duringsystole, by becoming tense and pulling the neo-leaflet 812, holding itin a closed coaptation position with the other valve leaflets.

The stabilizing means 817 comprises a weighted end 816 a distal from theneo-leaflet 812 that preferably assists via gravity, in the extension ofthe stabilizing means 817 in the ventricle. The weighted end 816 a maybe a free end which moves freely within the ventricle, or an end thatabuts against a ventricular wall to aid in the positioning of theneo-leaflet 812 at an intended location with respect to the heart valve.The stabilizing tethers 818 are attached to the weighted end 816 a. Inother embodiments, the stabilizing tethers 818 are attached to otherportions of the stabilizing means 817. In other various embodiments, theweighted end 816 a is a downstream anchoring means operable to anchor toa tissue site downstream with respect to the valve.

In other various embodiments, the stabilizing means 817 is attached tothe free end 812′ of the neo-leaflet 812, such that the stabilizingmeans 817 can be considered an extension of the neo-leaflet 812 and theweighted end 816 a can be considered an extension of the free end 812′.In such embodiments, the stabilizing means 817 may not comprisestabilizing tethers 818 since the weighted end 816 a would be sufficientto maintain the free end 812′ of the neo-leaflet 812 in the ventricle.

Methods of Delivery, Deployment and Implantation of the Cardiac ValveRepair Device

FIGS. 17A to 17F illustrate steps of a method for delivering, deployingand implanting a cardiac valve repair device 10 according to theembodiment shown in FIGS. 3 to 5, 14 and 15. The cardiac valve repairdevice 10 comprises an anchoring device, a stent 11, and a neo-leaflet12 which are separate components that are adapted to be connectedtogether in vivo.

Referring to FIG. 17A, the stent 11 is delivered via the inferior venacava 9 in a direction B to the coronary sinus 6 of a right heart atriumRA by a first delivery catheter 51. Access to the right heart atrium RAmay be from the femoral vein, internal jugular or subclavian vein. Aguide wire (not shown) may be used to guide the first delivery catheter51 to the intended location in the patient's heart. The stent 11 ispreferably crimped/compressed and may be enveloped (wholly or in part)by the delivery catheter, such that upon reaching the intended location,the stent 11 is unsheathed for the purposes of anchoring to an upstreamtissue site. The stent 11 is preferably crimped/compressed duringtranscatheter delivery to allow for relatively smooth tracking of thesystem through the blood vessels to an intended tissue site. Further, itallows the stent 11 to fit within a lumen of a blood vessel (e.g.coronary sinus) that is intended to be the upstream tissue site foranchorage. The stent 11 is positioned by the first delivery catheter 51within the coronary sinus 6 such that upon anchorage, one end of thestent 11 is contiguous with the ostium 6 a of the coronary sinus 6, asshown in FIG. 17B.

Upon reaching the coronary sinus 6, the stent 11 is radially expanded byfor example a balloon catheter, to urge and secure the stent 11 againstand engage the luminal wall of the coronary sinus 6. The engagement ofthe stent 11 against the luminal wall of the coronary sinus 6 provides aresistive force that anchors the stent 11 within the coronary sinus 6.When expanded, the stent 11 is substantially rigid to prevent collapseof the stent 11 during operation of the cardiac valve repair device 10.After the stent 11 is anchored to the coronary sinus 6, the stability ofthe stent 11 may be tested by tug testing which includes tugging on thestent 11 to check if the stent 11 will dislodge from the coronary sinus6. The first delivery catheter 51 may be fully retracted for subsequentsteps of the method to take place.

A second delivery catheter 51′ delivers the neo-leaflet 12 in adirection B via the inferior vena cava 9 to the coronary sinus 6 wherethe stent 11 is anchored (FIG. 17C). A guide wire (not shown) may beused to guide the second delivery catheter 51′ to the coronary sinus 6.The neo-leaflet 12 is preferably compressible/crimpable and may beenveloped (wholly or in part) by the delivery catheter, such that uponreaching the intended location, the neo-leaflet 12 is unsheathed andunfurled for deployment. The neo-leaflet 12 is preferablycrimped/compressed during transcatheter delivery to allow for relativelysmooth tracking of the system through the blood vessels to the intendedlocation. In various embodiments, the neo-leaflet 12 is releasablyattached to an end of the second delivery catheter 51′. The seconddelivery catheter 51′ extends substantially within the coronary sinus 6in the direction B to contact the neo-leaflet 12 with the interiorsurface of the stent 11, which can assist in the positioning of theneo-leaflet 12 for attachment with the stent 11.

The second delivery catheter 51′ is thereafter moved in a direction B′(FIG. 17D) to position one end of the neo-leaflet 12 with an inferiorborder of the stent 11, where the neo-leaflet 12 is attached to theinferior border of the stent 11 via a connecting means (e.g.bioadhesives, stitchings, hooks and screws) as described herein. Asshown in FIG. 17E, the second delivery catheter 51′ is fully retractedand neo-leaflet 12 extends from the stent 11. In various embodiments,the neo-leaflet 12 naturally extends across the tricuspid valve 2 forcoaptation with at least one valve leaflet to prevent, reduce and/orminimize a backflow of blood. In other various embodiments and as shownin FIG. 17F, a guide wire 50 is advanced in a downstream direction C tourge the neo-leaflet 12 to position across the tricuspid valve 2.

FIGS. 18A to 18D illustrate steps of a method for delivering, deployingand implanting a cardiac valve repair device 610 according to theembodiment shown in FIGS. 12A and 12B.

The cardiac valve repair device 610 comprises a stent 611 and aneo-leaflet 612 which are unitary, or separate components that areadapted to be connected together ex vivo.

Referring to FIG. 18A, the cardiac valve repair device 610 is deliveredvia the inferior vena cave 9 the right side of a heart by a deliverycatheter 651. The device 610 is preferably compressible/crimpable andmay be enveloped (wholly or in part) by the delivery catheter, such thatupon reaching the intended location, the device 610 is unsheathed. Thedelivery catheter 651 is advanced to the right ventricle RV such that anend of the delivery catheter 651 is positioned within the rightventricle RV, so that upon unsheathing the device 610 (e.g. via anobturator), a free end of the neo-leaflet 612 may be positioned withinthe right ventricle RV and the neo-leaflet 612 extends across thetricuspid valve 2. The delivery catheter 651 is retracted in thedirection D to first expose and unsheathe the neo-leaflet 612 andthereafter the stent 611 (FIG. 18B).

The delivery catheter 651 continues moving in the direction D to locatethe stent 611 substantially within the inferior vena cave 9. The stent611 is connected/attached to the neo-leaflet 612 via tethers 613 toprovide sufficient length between the stent 611 and the neo-leaflet 612for the neo-leaflet 612 to extend across the tricuspid valve 2 duringoperation of the device 610.In various embodiments where the neo-leaflet612 is sufficiently long, one end of the neo-leaflet 612 isconnected/attached to one end of the stent 611 (e.g. with bioadhesives),without the use of tethers. When the stent 611 is located substantiallywithin the inferior vena cave 9, the stent 611 is radially expanded byfor example a balloon catheter, to urge and secure the stent 611 againstand engage the luminal wall of the inferior vena cave 9. The engagementof the stent 611 against the luminal wall of the inferior vena cave 9provides a resistive force that anchors the stent 611 within theinferior vena cave 9. When expanded, the stent 611 is substantiallyrigid to prevent collapse of the stent 611 during operation of thecardiac valve repair device 610. After the stent 611 is anchored to theinferior vena cave 9, the stability of the stent 611 may be tested bytug testing which includes tugging on the stent 611 to check if thestent 611 will dislodge from the inferior vena cave 9. The deliverycatheter 651 is then fully retracted to complete the implantation of thedevice 610 (FIG. 18D), where the neo-leaflet 612 extends across thetricuspid valve 2.

FIGS. 19A to 19D illustrate steps of another method for delivering,deploying and implanting a cardiac valve repair device 610 according tothe embodiment shown in FIGS. 12A and 12B. The cardiac valve repairdevice 610 comprises a stent 611 and a neo-leaflet 612 which areseparate components that are adapted to be connected together in vivo.

Referring to FIG. 19A, the stent 611 is delivered to the inferior venacava 9 by a first delivery catheter (not shown). Upon reaching theinferior vena cava 9, the crimped/compressed stent 611 is radiallyexpanded by for example a balloon catheter, to urge the stent 611against and engage the luminal wall of the inferior vena cave 9. Theengagement of the stent 611 against the luminal wall of the inferiorvena cava 9 provides a resistive force that anchors the stent 611 withinthe inferior vena cave 9. When expanded, the stent 611 is substantiallyrigid to prevent collapse of the stent 611 during operation of thecardiac valve repair device 610. After the stent 611 is anchored to theinferior vena cava 9, the stability of the stent 611 may be tested bytug testing which includes tugging on the stent 611 to check if thestent 611 will dislodge from the inferior vena cava 9.

A second delivery catheter 651′ delivers in a direction E, theneo-leaflet 612 via the inferior vena cava 9 and through the stent 611,to the right heart atrium RA and the right heart ventricle RV (FIGS. 19Band 19C). The delivery catheter 651′ is advanced to the right ventricleRV such that an end of the delivery catheter 651′ is positioned withinthe right ventricle RV, so that upon unsheathing the neo-leaflet 612(e.g. by an obturator), a free end of the neo-leaflet 612 may bepositioned within the right ventricle RV and the neo-leaflet 612 mayextend across the tricuspid valve 2. The delivery catheter 651 isretracted in the direction E′ to expose and unsheathe the neo-leaflet612 (FIG. 19C), and to bring one end of the neo-leaflet 612 close to thestent 611.

After the neo-leaflet 612 has been positioned to extend across thetricuspid valve 2, the neo-leaflet 612 is connected to the stent 611 viatethers 613. The tethers 613 provide sufficient length between the stent611 and the neo-leaflet 612 for the neo-leaflet 612 to extend across thetricuspid valve 2 during operation of the device 610. In variousembodiments where the neo-leaflet 612 is sufficiently long, one end ofthe neo-leaflet 612 is connected/attached to one end of the stent 611(e.g. with bioadhesives), without the use of tethers.

It should be understood that while certain variants of the presentinvention are illustrated and described herein, the invention is definedby the description and is not to be limited to the specific embodimentsdescribed and shown in the figures. For example, according to theinvention is also conceivable that:

-   -   the upstream anchoring means described herein as a stent can be        made of another anchoring expandable structure or a screw;    -   the coaptation structure deployed inside a patient's heart valve        to restore valve function can be a spherical or tubular member        or a prosthetic replacement valve;    -   the device of the present invention can be applied to valve        anatomies other than the tricuspid valve, for example the mitral        valve;    -   the device of the present invention can comprise methods of        delivering, deploying and anchoring/implanting the        neo-leaflet/flap to restore valve function and coaptation of the        valve leaflets, other than the methods described herein; and    -   various components of the cardiac valve repair device can be        combined with one another even if not explicitly disclosed, for        example, the device can comprise a superior vena cava anchoring        stent, a neo-leaflet that extends onto the anterior leaflet of a        tricuspid valve and into the right ventricle, and a stabilizing        means that extends further into the right ventricle with respect        to the neo-leaflet, where the stabilizing means maintains a free        end of the neo-leaflet in the ventricle.

REFERENCES

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2. McCarthy P M, Bhudia S K, Rajeswaran J, et al. Tricuspid valverepair: durability and risk factors for failure. The Journal of thoracicand cardiovascular surgery 2004; 127:674-85.

3. Ghanta R K, Chen R, Narayanasamy N, et al. Suture bicuspidization ofthe tricuspid valve versus ring annuloplasty for repair of functionaltricuspid regurgitation: midterm results of 237 consecutive patients.The Journal of thoracic and cardiovascular surgery 2007; 133:117-26.

4. Singh J P, Evans J C, Levy D, et al. Prevalence and clinicaldeterminants of mitral, tricuspid, and aortic regurgitation (theFramingham Heart Study). The American journal of cardiology 1999;83:897-902.

5. Nath J, Foster E, Heidenreich P A. Impact of tricuspid regurgitationon long-term survival. Journal of the American College of Cardiology2004; 43:405-9.

6. Izumi C, Iga K, Konishi T. Progression of isolated tricuspidregurgitation late after mitral valve surgery for rheumatic mitral valvedisease. The Journal of heart valve disease 2002; 11:353-6.

7. Porter A, Shapira Y, Wurzel M, et al. Tricuspid regurgitation lateafter mitral valve replacement: clinical and echocardiographicevaluation. The Journal of heart valve disease 1999; 8:57-62.

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1. A device for cardiac valve repair, the device comprising: at leastone upstream anchoring means adapted to anchor to at least one tissuesite, the tissue site located upstream with respect to a heart valve ofa patient; and a coaptation structure arranged to extend from theupstream anchoring means, the coaptation structure comprising a freeend, wherein the coaptation structure is operable to extend across theheart valve and locate the free end downstream from the heart valve andthe coaptation structure operable to coapt with at least one heart valveleaflet of the patient's heart to prevent and/or minimize a backflow ofblood. 2-17. (canceled)
 18. The device according to claim 1, wherein theupstream tissue site is a blood vessel and the upstream anchoring meansis a stent. 19-22. (canceled)
 23. The device according to claim 18,wherein the heart valve is a mitral valve and the stent is adapted toanchor at a pulmonary vein of the patient's heart. 24-26. (canceled) 27.A method of implanting a device for cardiac valve repair in a patient'sheart, the method comprising the steps of: a) delivering a device forcardiac valve repair to the patient's heart, the device comprising atleast one upstream anchoring means and a coaptation structure arrangedto extend from the upstream anchoring means; b) anchoring the upstreamanchoring means to at least one tissue site in the patient's heart, thetissue site located upstream with respect to a heart valve of thepatient's heart; c) deploying the coaptation structure to extend acrossthe heart valve to locate a free end of the coaptation structuredownstream from the heart valve, and for the coaptation structure tocoapt with at least one heart valve leaflet of the patient's heart toprevent and/or minimize a backflow of blood. 28-30. (canceled)
 31. Themethod according to claim 27, wherein the method further comprises thestep of testing and verifying the stability of the upstream anchoringmeans. 32-33. (canceled)
 34. The method according to claim 27, whereinthe upstream anchoring means is a stent and the method comprisesanchoring the stent at the coronary sinus of the right atrium of thepatient's heart, and deploying the coaptation structure such that thefree end of the coaptation structure extends into the right heartventricle of the patient and the coaptation structure coapts with atleast one tricuspid valve leaflet of the patient's heart.
 35. The methodaccording to claim 27, wherein the upstream anchoring means is a stentand the method comprises anchoring the stent at the inferior vena cavaof the patient, and deploying the coaptation structure such that thefree end of the coaptation structure extends into the right heartventricle of the patient and the coaptation structure coapts with atleast one tricuspid valve leaflet of the patient's heart.
 36. (canceled)37. The method according to claim 27, wherein the upstream anchoringmeans is a stent and the method comprises anchoring the stent at apulmonary vein of the left atrium of the patient's heart, and deployingthe coaptation structure such that the free end of the coaptationstructure extends into the left heart ventricle of the patient and thecoaptation structure coapts with at least one mitral valve leaflet ofthe patient's heart.
 38. The method according to claim 27, wherein thedelivery of the cardiac valve repair device is via transcatheterdelivery. 39-46. (canceled)
 47. A device for cardiac valve repair, thedevice comprising: an upstream anchoring means adapted to anchor to anupstream tissue site, the upstream tissue site located upstream withrespect to a heart valve of a patient; and a neo-leaflet arranged toextend from the upstream anchoring means, wherein the neo-leaflet issperable to extend across the heart valve and the coaptation structureis operable to coapt with at least one heart valve leaflet of thepatient's heart to prevent and/or minimize a backflow of blood.
 48. Thedevice according to claim 47, wherein the device comprises a downstreamanchoring means configured to extend from an end of the neo-leaflet, andwherein the downstream anchoring means is adapted to anchor at adownstream tissue site with respect to the heart valve of the patient.49. The device according to claim 48, wherein the downstream tissue siteis an endocardial or pericardial tissue site of a heart ventricle of thepatient.
 50. The device according to claim 47, wherein the upstreamanchoring means is adapted to anchor at the coronary sinus of thepatient's heart.
 51. The device according to claim 47, wherein theupstream anchoring means is adapted to anchor to a pulmonary vein of thepatient's heart.
 52. The device according to claim 1, wherein coaptationstructure is selected from a group consisting of: (a) a flexiblecoaptation structure; (b) a balloon having a surface for coaptation ofat least one heart valve leaflet of the patient's heart; (c) a membrane,wherein a portion of the membrane is extendable into a commissurebetween two adjacent heart valve leaflets of the patient's heart; and(d) a neo-leaflet.
 53. The device of claim 52, wherein the neo-leafletis selected from a group consisting of: (i) a flexible structure, (ii) apolymer, fabric, tissue or combination thereof, and (iii) an expandablestructure extendable onto a surface of at least one heart valve leafletof the patient's heart.
 54. The device according to claim 52, whereinthe device comprises a stabilizing structure adapted to extend acrossthe heart valve of the patient, and wherein the stabilizing structure isconfigured to maintain the downstream location of the free end ofneo-leaflet wherein the stabilizing structure is selected from a groupconsisting of: (a) the stabilizing structure having a weighted free end;or (b) one or more stabilizing tether adapted to connect the stabilizingstructure to the neo-leaflet.
 55. The device according to claim 18,wherein the heart valve is a tricuspid valve, wherein the stent isadapted to: (a) anchor at the coronary sinus of the patient's heart; or(b) anchor at the inferior vena cava of the patient.
 56. The deviceaccording to claim 52, the device further comprising a connecting meansadapted to connect the upstream anchoring means and the balloon, whereinthe connecting means is adapted to arrange the balloon at a firstlocation between two or more heart valve leaflets of the patient'sheart.
 57. The device according to claim 52, the device furthercomprising a connecting means adapted to connect the upstream anchoringmeans and the neo-leaflet, wherein the connecting means is adapted toarrange a portion of the neo-leaflet at a first location between two ormore heart valve leaflets of the patient's heart.
 58. The deviceaccording to claim 52, wherein at least a portion of the neo-leaflet isextendable into a commissure between two adjacent heart valve leafletsof the patient's heart.